Fujifilm Eb-530H
Fujifilm Eb-530H is a flexible video bronchoscope (FDA Class II; FDA product code EOQ, Bronchoscope (Flexible or Rigid)) made by Fujifilm Corporation, cleared under FDA 510(k) K182253 on 4 Apr 2019 (1 earlier submission) and listed in FDA GUDID since 14 Dec 2016 (UDI-DI 04547410330168), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182253 | Date4 Apr 2019 | StatusActive |
| United States | GUDID listing | Number04547410330168 | Date14 Dec 2016 | StatusListed |
Official records
- AccessGUDID record 04547410330168
- FDA 510(k) database K182253
- FDA 510(k) database K122535
Across registries
- FDA 510(k) K182253 decided 4 Apr 2019 Active
- FDA GUDID UDI-DI 04547410330168 listed 14 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K122535
- Listed FDA GUDID 04547410330168
- Cleared FDA 510(k) K182253
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fujifilm
- Generic name
- Flexible video bronchoscope, reusable
- Model / reference
- EB-530H
- Primary DI / UDI-DI
- 04547410330168
- FDA product code
- EOQ
- GMDN term
- Flexible video bronchoscope, reusable
- Device class
- Class II
- Regulation number
- 874.4680
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Flexible video bronchoscope, reusable.